Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02286622 | A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics | PHASE1 | COMPLETED | 16 | — | — | Dec 1, 2014 | Feb 1, 2015 | Aug 18, 2017 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Renal Impairment | EXPERIMENTAL | Eight (8) subjects with ESRD on HD will receive one 18 mg dose of deflazacort. |
| Healthy Volunteers | EXPERIMENTAL | Eight (8) healthy subjects with estimated creatinine clearance (CLcr) ≥ 90 mL/min. Subjects will be matched for age \[± 15 years\], BMI \[± 15 %\], and gender \[1:1\] to the subjects in the ESRD cohort. Subjects will receive one 18 mg dose of deflazacort. |
| Name | Type | Description |
|---|---|---|
| Deflazacort | DRUG | Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite 21-desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone |
Inclusion Criteria: * Continuous non-smokers or moderate smokers * For a female of non-childbearing potential: must have undergone a sterilization procedures or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and FSH serum levels consistent with postmenopausal status *...